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FDA 510(k)

GEN5 and GEN5+ Dental Implant System

K-Number: K251938 · 2025-10-30

ApplicantParagon Implant Mfg., LLC
Decision Date2025-10-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GEN5 and GEN5+ Dental Implant System is a medical device manufactured by Paragon Implant Mfg., LLC. It received FDA 510(k) clearance on 2025-10-30 under approval number K251938. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GEN5 and GEN5+ Dental Implant System?

GEN5 and GEN5+ Dental Implant System is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Paragon Implant Mfg., LLC. The 510(k) number is K251938.

When was GEN5 and GEN5+ Dental Implant System approved by the FDA?

GEN5 and GEN5+ Dental Implant System received FDA 510(k) clearance on 2025-10-30, under approval number K251938.

What company makes GEN5 and GEN5+ Dental Implant System?

GEN5 and GEN5+ Dental Implant System is manufactured by Paragon Implant Mfg., LLC.

What is the FDA product code for GEN5 and GEN5+ Dental Implant System?

The FDA product code for GEN5 and GEN5+ Dental Implant System is DZE.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Paragon Implant Mfg., LLC

K250476NizPlant Dental Implant System K252145GEN5™ and GEN5+™ 3.3mmD Dental Implants K251756Sterilization Trays

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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